by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XV – Safety Communication 📘 Purpose GVP Module XV provides guidance on how Marketing Authorization Holders (MAHs) and Regulatory Authorities should effectively communicate safety information about medicinal products to healthcare professionals, patients,...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module X – Additional Monitoring 📘 Purpose GVP Module X outlines the principles and procedures related to “Additional Monitoring” of certain medicines to enhance early identification of new safety information. It ensures transparency and helps promote reporting...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module IX – Signal Management 📘 Purpose GVP Module IX provides comprehensive guidance for Marketing Authorisation Holders (MAHs) and regulatory authorities on how to perform signal management, which is a core part of pharmacovigilance. The goal is to ensure...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VIII – Post-Authorization Safety Studies (PASS) 📘 Purpose GVP Module VIII provides guidance on the design, conduct, and reporting of Post-Authorization Safety Studies (PASS) conducted by Marketing Authorization Holders (MAHs) after a product has been...
